Genesis R&D® Foods turns 30 this year, just one year after the same milestone for the Nutrition Labeling and Education Act of 1990 (NLEA). This is not a coincidence.
In fact, ESHA Research introduced Genesis R&D in 1991 to help manufacturers comply with the NLEA, which codified nutrition labeling. For the first time, the NLEA mandated nutrition labels on packaged foods and standardized the layout, serving sizes, and allowable health or nutrition claims.
Evolution of Genesis R&D
Before the NLEA was introduced, ESHA Research had already released a nutrition analysis software with an integrated food and ingredient database, the popular Food Processor. Many food manufacturers, it turned out, were trying to use Food Processor to calculate the nutritional analysis of their recipe for food labels.
During a tradeshow, some of these manufacturers approached ESHA, asking for additional features and specific industry ingredients in order to be able to build their labels correctly.
ESHA thoroughly researched and reviewed NLEA laws and the FDA regulations and concluded that, instead, an entirely new software program was warranted. Thus, Genesis R&D was born. Genesis R&D was the first software program able to deliver the full required nutrition analysis and generate a Nutrition Facts label.
ESHA Research was established in 1981 by Elizabeth S. Hands and Associates. Hands had been looking into the connection between nutrition and her mother’s health issues, and discovered an alarming lack of information, so she began compiling her own data. When researchers and academics took interest in the database, Robert Geltz, her husband and ESHA’s co-founder, used his then-nascent programming skills to manage the data and create a software program to make the data useable to others.
At that time, however, the FDA was wary of allowing computer analysis as an accepted method for nutrition label data.
Food industry scientists were just starting to use computers and most nutrition analysis was still done through labs. So ESHA, through a series of meetings, set out to show the FDA that computerized analysis using a database was just as accurate as lab analysis.
The FDA often performed more than one lab test on a product and averaged the results to compare to the package label. ESHA demonstrated that its database also used average values from a wide variety of sources. After comparing the results of lab vs. database analysis, the FDA concurred that computerized database analysis was indeed accurate.
And they wanted to see more.
“Initially the FDA had few computers but that was changing rapidly. They were very interested and wanted to see what they were likely to encounter when they visited food companies, who were starting to adopt computer technology. Eventually, the FDA bought Genesis R&D to get an idea of what results they might expect during their inspections. Soon, the agency was holding workshops about labeling that included discussions about new software advances, and we were invited to present what Genesis R&D software could do.
Now, Final FDA guidance allows the use of databases as an accepted method for developing nutrition labels.
The growth of Genesis R&D has always been in tandem with the growth of the NLEA. Every time the regulations are amended, or a new provision is added, Genesis R&D reflects the change.
Most recently, as the FDA was revamping the Nutrition Facts Panel, ESHA monitored every modification. Less than two months after the final regulations were published, Genesis R&D was updated with the new Nutrition Facts Label layout and nutrient requirements.
In 2016, responding to customer and industry requests, ESHA developed an offshoot of Genesis R&D to specifically address the needs of the supplement manufacturing industry — Genesis R&D Supplement Formulation & Labeling Software.
So, the history of Genesis R&D is, essentially, the history of nutrition and supplement labeling. And they both go much further back than three decades.
History Leading Up to the NLEA
Before 1990, provisions in the Food, Drug, and Cosmetic Act (FD&C Act) of 1938 regulated the labeling of foods. The mandatory nutrition labeling of packaged foods was primarily limited to foods making nutrition claims or foods fortified with vitamins, minerals, or protein.
The FD&C Act of 1938 itself was the FDA’s answer to public outcry over the shortcomings of the first food consumer safety laws — the 1906 Pure Food and Drugs Act (PFDA).
The 1906 act was passed to prevent “…the Manufacture, Sale, or Transportation of Adulterated or Misbranded or Poisonous or Deleterious Foods, Drugs, Medicines, and Liquors, and for Regulating Traffic Therein, and for Other Purposes,” but it soon proved to be woefully inadequate in preventing poisoning, or even death. For example, manufacturers were still legally able to sell attractively packaged and widely advertised products like “BRED-SPRED,” (made of coal tar, artificial pectin, artificial flavors, and grass seeds) sold as food.
To fix the issues in the PFDA, the FDA in 1933 submitted a complete revision. However, it wasn’t until 5 years later, after over 100 people died from using a new therapeutic “wonder drug” called Elixir Sulfanilamide, that the FD&C Act of 1938 was finally signed into law.
It took 52 more years to get to 1990’s NLEA and 83 years to get to where we are now. Let’s take a look at some of the regulatory highlights.
Timeline: History of Food Labeling Laws
Between 1879 and 2016, nearly 100 bills regulating the sale of food and drugs have been introduced in Congress.
